Cleared Traditional

RELIEVA ULTIRRA Sinus Balloon Catheter

K190525 · Acclarent, Inc. · Ear, Nose, Throat
May 2019
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K190525 is an FDA 510(k) clearance for the RELIEVA ULTIRRA Sinus Balloon Catheter, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Acclarent, Inc. (Irvin, US). The FDA issued a Cleared decision on May 3, 2019, 60 days after receiving the submission on March 4, 2019. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K190525 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2019
Decision Date May 03, 2019
Days to Decision 60 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LRC — Instrument, Ent Manual Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4420